ATE2192T1 - PROCESS FOR PREPARING AN IMMUNOGLOBULIN SOLUTION CONTAINING IGM IN CONCENTRATED FORM FOR INTRAVENOUS APPLICATION. - Google Patents
PROCESS FOR PREPARING AN IMMUNOGLOBULIN SOLUTION CONTAINING IGM IN CONCENTRATED FORM FOR INTRAVENOUS APPLICATION.Info
- Publication number
- ATE2192T1 ATE2192T1 AT80100087T AT80100087T ATE2192T1 AT E2192 T1 ATE2192 T1 AT E2192T1 AT 80100087 T AT80100087 T AT 80100087T AT 80100087 T AT80100087 T AT 80100087T AT E2192 T1 ATE2192 T1 AT E2192T1
- Authority
- AT
- Austria
- Prior art keywords
- igm
- propiolactone
- beta
- solution
- treatment
- Prior art date
Links
- 108060003951 Immunoglobulin Proteins 0.000 title abstract 2
- 102000018358 immunoglobulin Human genes 0.000 title abstract 2
- 238000001990 intravenous administration Methods 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title 1
- VEZXCJBBBCKRPI-UHFFFAOYSA-N beta-propiolactone Chemical compound O=C1CCO1 VEZXCJBBBCKRPI-UHFFFAOYSA-N 0.000 abstract 4
- 229960000380 propiolactone Drugs 0.000 abstract 4
- 108090000623 proteins and genes Proteins 0.000 abstract 4
- 102000004169 proteins and genes Human genes 0.000 abstract 4
- 239000000243 solution Substances 0.000 abstract 3
- 210000002381 plasma Anatomy 0.000 abstract 2
- JVIPLYCGEZUBIO-UHFFFAOYSA-N 2-(4-fluorophenyl)-1,3-dioxoisoindole-5-carboxylic acid Chemical compound O=C1C2=CC(C(=O)O)=CC=C2C(=O)N1C1=CC=C(F)C=C1 JVIPLYCGEZUBIO-UHFFFAOYSA-N 0.000 abstract 1
- 108010044316 Cohn fraction III Proteins 0.000 abstract 1
- 229920002307 Dextran Polymers 0.000 abstract 1
- 229920001425 Diethylaminoethyl cellulose Polymers 0.000 abstract 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 abstract 1
- 239000008119 colloidal silica Substances 0.000 abstract 1
- 238000005194 fractionation Methods 0.000 abstract 1
- 150000002632 lipids Chemical class 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000002504 physiological saline solution Substances 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 abstract 1
- 210000002966 serum Anatomy 0.000 abstract 1
- 229910002027 silica gel Inorganic materials 0.000 abstract 1
- 239000007858 starting material Substances 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S424/00—Drug, bio-affecting and body treating compositions
- Y10S424/806—Drug, bio-affecting and body treating compositions involving IgM
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
- Y10S530/827—Proteins from mammals or birds
- Y10S530/829—Blood
- Y10S530/83—Plasma; serum
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
- Y10S530/827—Proteins from mammals or birds
- Y10S530/829—Blood
- Y10S530/83—Plasma; serum
- Y10S530/831—Cohn fractions
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
- Y10S530/827—Proteins from mammals or birds
- Y10S530/832—Milk; colostrum
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
- Y10S530/863—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof involving IgM
Landscapes
- Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Mycology (AREA)
- Animal Behavior & Ethology (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
A process for the preparation of an immunoglobulin solution containing IgM in concentrated form and suited for intravenous administration, comprising treating an IgM-containing protein fraction obtained by conventional fractionation from blood plasma or serum with beta -propiolactone in an amount such that the ratio of beta -propiolactone to a 5% solution of the IgM-containing proteins is from about 0.05 to 0.15 ml per 100 ml. Advantageously, prior to the treatment with beta -propiolactone the IgM-containing protein fraction is freed of lipids by treatment with colloidal silica gel and with crosslinked dextrans or diethylaminoethyl cellulose. The starting material used is a Cohn fraction III of human blood plasma which has been dissolved in physiological saline solution to a concentration of about 5% protein, the treatment with beta -propiolactone is carried out at about 20 DEG to 37 DEG C. for about 4 to 6 hours until a substantially constant pH of about 8 is obtained, and the solution is thereafter sterile filtered.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19792901822 DE2901822A1 (en) | 1979-01-18 | 1979-01-18 | METHOD FOR THE PRODUCTION OF AN IMMUNOGLOBULIN SOLUTION SUITABLE FOR THE INTRAVENOUS APPLICATION THAT IGM CONTAINS IN A CONCENTRATED FORM |
| EP80100087A EP0013901B1 (en) | 1979-01-18 | 1980-01-09 | Process of preparation of an intravenous immunoglobulin solution, containing concentrated igm |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ATE2192T1 true ATE2192T1 (en) | 1983-01-15 |
Family
ID=6060836
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AT80100087T ATE2192T1 (en) | 1979-01-18 | 1980-01-09 | PROCESS FOR PREPARING AN IMMUNOGLOBULIN SOLUTION CONTAINING IGM IN CONCENTRATED FORM FOR INTRAVENOUS APPLICATION. |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US4318902A (en) |
| EP (1) | EP0013901B1 (en) |
| AT (1) | ATE2192T1 (en) |
| DE (2) | DE2901822A1 (en) |
Families Citing this family (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3033932C2 (en) * | 1980-09-10 | 1984-05-24 | Biotest-Serum-Institut Gmbh, 6000 Frankfurt | Process for the cold sterilization of preparations containing blood coagulation factor VIII |
| US4775638A (en) * | 1985-05-08 | 1988-10-04 | Centocor, Inc. | Single vial technique for radiolabeling protein |
| JPH0662436B2 (en) * | 1986-05-19 | 1994-08-17 | 株式会社ミドリ十字 | Method for producing intravenous immunoglobulin preparation |
| DE3640513A1 (en) * | 1986-11-27 | 1988-06-09 | Biotest Pharma Gmbh | METHOD FOR THE PRODUCTION OF A VIRUS-SAFE, STORAGE-STABLE AND INTRAVENOES COMPATIBLE IMMUNGLOBULIN-G-PRAEPARATES |
| DE3641115A1 (en) * | 1986-12-02 | 1988-06-16 | Lentia Gmbh | METHOD FOR PRODUCING AN INTRAVENOUS APPLICABLE AND STABLE IN LIQUID FORM IMMUNOGLOBULINS |
| US4841026A (en) * | 1987-01-27 | 1989-06-20 | Miles Laboratories, Inc. | Virally inactivated, non-toxic, human transferrin preparation |
| US5157113A (en) * | 1987-08-10 | 1992-10-20 | Miles Inc. | Removal of nucleic acids from monoclonal antibody preparations |
| DE3825429C2 (en) * | 1988-07-27 | 1994-02-10 | Biotest Pharma Gmbh | Method for producing an intravenously administrable polyclonal immunoglobulin preparation with a high IgM content |
| DE3927111C3 (en) * | 1989-08-17 | 1994-09-01 | Biotest Pharma Gmbh | Process for the preparation of unmodified intravenous IgM and / or IgA-containing immunoglobulin preparations |
| DE3927112C1 (en) * | 1989-08-17 | 1990-10-25 | Biotest Pharma Gmbh, 6072 Dreieich, De | |
| US5256771A (en) * | 1990-04-03 | 1993-10-26 | Miles Inc. | Heat treatment of IgM-containing immunoglobulins to eliminate non-specific complement activation |
| US5219578A (en) * | 1991-02-25 | 1993-06-15 | Innovet, Inc. | Composition and method for immunostimulation in mammals |
| EP0835880A1 (en) * | 1996-10-14 | 1998-04-15 | Rotkreuzstiftung Zentrallaboratorium Blutspendedienst Srk | Process for producing an IgM preparation for intravenous administration |
| CA2232420A1 (en) * | 1997-03-19 | 1998-09-19 | The Green Cross Corporation | Immunoglobulin preparation and preparation process thereof |
| US6610293B1 (en) * | 1997-06-16 | 2003-08-26 | The Henry M. Jackson Foundation For The Advancement Of Military Medicine | Opsonic and protective monoclonal and chimeric antibodies specific for lipoteichoic acid of gram positive bacteria |
| US6692739B1 (en) | 1998-08-31 | 2004-02-17 | Inhibitex, Inc. | Staphylococcal immunotherapeutics via donor selection and donor stimulation |
| US20070049732A1 (en) * | 2005-09-01 | 2007-03-01 | Zurlo Eugene J | Ultra-high yield intravenous immune globulin preparation |
| US7879332B2 (en) * | 2005-09-01 | 2011-02-01 | Plasma Technologies, Llc | Ultra-high yield intravenous immune globulin preparation |
| US8293242B2 (en) * | 2005-09-01 | 2012-10-23 | Plasma Technologies, Llc | Ultra-high yield of alpha-1-anti-trypsin |
| DE102007001521A1 (en) * | 2007-01-10 | 2008-07-17 | Matthias, Torsten, Dr. | Use of Cohn-Oncley fractions II and II / III for the treatment of systemic lupus erythematosus |
| GB201006753D0 (en) * | 2010-04-22 | 2010-06-09 | Biotest Ag | Process for preparing an immunolobulin composition |
| US8772462B2 (en) | 2010-05-26 | 2014-07-08 | Baxter International Inc. | Removal of serine proteases by treatment with finely divided silicon dioxide |
| AU2010202125B1 (en) | 2010-05-26 | 2010-09-02 | Takeda Pharmaceutical Company Limited | A method to produce an immunoglobulin preparation with improved yield |
| RU2470664C2 (en) * | 2010-08-23 | 2012-12-27 | Андрей Германович Лютов | Method for producing immunoglobulin for intravenous introduction of immunoglobulin m enriched preparation, and preparation prepared by such method |
| RU2735680C2 (en) | 2016-03-14 | 2020-11-05 | Биотест Аг | Treatment of severe community-acquired pneumonia |
| EP3275897A1 (en) | 2016-07-27 | 2018-01-31 | Biotest AG | Process for preparing immunoglobulin compositions |
| US10259865B2 (en) | 2017-03-15 | 2019-04-16 | Adma Biologics, Inc. | Anti-pneumococcal hyperimmune globulin for the treatment and prevention of pneumococcal infection |
| CN111000253A (en) * | 2019-12-03 | 2020-04-14 | 武汉跃莱健康产业有限公司 | Composite polypeptide protein powder and preparation method thereof |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB872122A (en) | 1958-06-13 | 1961-07-05 | Joos Bernhard | Stabilizing sera |
| NL240154A (en) | 1959-06-12 | |||
| DE1792555C3 (en) * | 1968-09-19 | 1980-01-10 | Biotest-Serum-Institut Gmbh, 6000 Frankfurt | Process for the preparation of a gamma globulin solution suitable for intravenous use |
| US3597409A (en) * | 1970-05-25 | 1971-08-03 | American Cyanamid Co | Process for recoverring immunoglobulin a and immunoglobulin m |
-
1979
- 1979-01-18 DE DE19792901822 patent/DE2901822A1/en not_active Withdrawn
-
1980
- 1980-01-07 US US06/110,038 patent/US4318902A/en not_active Expired - Lifetime
- 1980-01-09 DE DE8080100087T patent/DE3061547D1/en not_active Expired
- 1980-01-09 AT AT80100087T patent/ATE2192T1/en active
- 1980-01-09 EP EP80100087A patent/EP0013901B1/en not_active Expired
Also Published As
| Publication number | Publication date |
|---|---|
| US4318902A (en) | 1982-03-09 |
| DE3061547D1 (en) | 1983-02-17 |
| EP0013901B1 (en) | 1983-01-12 |
| EP0013901A1 (en) | 1980-08-06 |
| DE2901822A1 (en) | 1980-07-31 |
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